MTEK Sciences specializes in utilizing real-world evidence to its' greatest potential, utilizing innovative methods such as microsimulations, machine learning models and Bayesian dynamic borrowing.
Synthetic and External Controls
Leveraging the most out of existing real-world evidence is a cornerstone philosophy of our synthetic control services. Assigning participants to control arms can be logistically, ethically or financially challenging in clinical trials. Historically, regulatory submissions for agents that have not been assessed in comparative efficacy trials have relied on dramatic treatment effects and high unmet need to assuage health regulatory assessors. As diseases and treatments become increasingly fragmented owing to advances in genomic and pathophysiological understanding, methods to minimize assignment to control therapy become increasingly important. We harness the latest advances in Bayesian dynamic borrowing, propensity score adjustment and epidemiological microsimulation modelling to derive synthetic controls capable of standing up to clinical and regulatory scrutiny.
Disease Modeling and Microsimulations
As patient populations become increasingly mapped and data is generated, there is a need for methodologies to utilize this knowledge for maximum impact and to create end-to-end hypothesis to impact research paradigms. To achieve this, we apply a multitude of methodologies and areas of expertise including patient-level health trajectory microsimulation, machine learning algorithms, and Bayesian risk prediction. Through a mixture of these methodologies we generate dynamic and representative disease models that are responsive to continual and agile data review by expert multidisciplinary teams.
Highly Efficient Clinical Trial (HECT) design and simulations
Clinical trials are large investments. There is an important need to minimize costs, reduce the number of participants included, mitigate risks, and arrive at a reliable answer as fast as possible. Preliminary clinical trial microsimulations can substantially help gauge the likelihood of success and failure with multiple candidate designs. Whether adaptive, group sequential, or conventional design; phase II, III, IV, seamless or perpetual; our team of clinical epidemiologists and biostatisticians can help ensure a better likelihood of achieving an answer quickly and minimizing your investment for your clinical trial. We call this Highly Efficient Clinical Trials (HECT) and believe it represents a paradigm shift in clinical trials.